Samsung RT34M Uživatelský manuál stáhnout pdf (Strana 89)

Dushyant Patel Extractive Spectrophotometric Method

S.K.P.C.P.E.R., Kherva 77 M .Pharm. Thesis

5.3.4 Intermediate precision (Reproducibility):

¾ The low % RSD values of interday (0.77% -1.90 % for BCG and 0.87% -1.77% for

BTB) and intraday (0.14%-1.08 % for BCG and 0.31%-1.63% for BTB) variations

reveal that the proposed methods provide acceptable intraday and interday variation for

GBP at different concentration levels (calibration range concentration for BCG and

BTB) (Table No. 5.1).

5.3.5 Limit of detection (LOD) and Limit of quantification (LOQ):

¾ LOD and LOQ values for GBP were found to be 2.90 µg/ml and 8.77 µg/ml, respectively

for BCG and 10.86 µg/ml and 32.91 µg/ml for BTB, respectively. These data show that

this method is sensitive for the determination of GBP (Table No. 5.1).

5.3.6 Assay of the pharmaceutical formulations:

¾ The proposed validated methods were successfully applied to determine GBP in its

dosage forms. The results obtained were comparable with the corresponding labeled

amount (Table No. 5.5 and 5.6). No interference of the excipients with the absorbance of

interest appeared; hence the proposed methods are applicable for the routine estimation

of GBP in pharmaceutical dosage forms.

TABLE NO: 5.5

ANALYSIS OF MARKETED FORMULATION (CAPSULE DOSAGE FORM) OF

GBP BY PROPOSED METHODS (n = 6)

Sample No.

Label Claim Amount Found % Label Claim

GBP

(mg/cap)

GBP

(mg/cap)

GBP

(mg/cap)

BCG BTB BCG BTB

300 301.1 298.6 100.4 99.52

300 304.8 297.7 101.6 99.22

300 302.0 297.0 100.7 99.01

300 301.1 297.9 100.4 99.32

300 297.3 296.7 99.11 98.91

300 304.8 298.8 101.6 99.62

Mean

100.6 99.27

0.93 0.28

1 2 ... 84 85 86 87 88 89 90 91 92 93

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